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Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44HL112484-02
Agency Tracking Number: R44HL112484
Amount: $1,517,476.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA13-234
Solicitation Year: 2014
Award Year: 2014
Award Start Date (Proposal Award Date): 2014-05-01
Award End Date (Contract End Date): 2016-04-30
Small Business Information
Houston, TX 77024-6918
United States
DUNS: 967229746
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (713) 798-4783
Business Contact
Phone: (281) 639-1260
Research Institution

DESCRIPTION provided by applicant The Specific Aim of this proposal is to file an IND to allow for a Phase I clinical safety study of FGH with an indication for the control of obesity We successfully met the primary endpoints of our SBIR Phase I study R HL As shown by the Phase I report of this proposal following oral gavage significant control of weight gain and improvement in body composition was observed with a therapeutic index TI of at least in high fat high carbohydrate HFHC fed rats We are submitting this SBIR Phase II proposal to develop our compound to the IND stage Obesity and excess fat is a major risk factor for cardiovascular disease diabetes mellitus and cancers among other chronic diseases Diet and exercise are the mainstays of weight loss programs but in most cases they are not sufficient to address the problem Prescription drugs are widely used to treat obesity but
they generally have limited efficacy seldom work without significant lifestyle modification stric control of diet and exercise and they can have serious side effects Targeting individual enzymes in lipid and fat metabolism has been used to develop drugs against obesity and related complications however these efforts have not proven effective clinically due to lack of efficacy or intolerable side effects Therefore we have taken a new mechanistic approach with the goal of finding a drug that will help control weight without dose limiting unwanted side effects To this end we identified a small molecule FGH that targets master regulators of multiple pathways of lipid and fat synthesis which are important elements in adipogenesis and developing obesity FGH is an orally available small molecule diarylthiazole FGH blocks the activity of transcription factors SREBP and master regulators of fat and lipid synthesis Oral administration of FGH resulted in weight loss at mg kg and loss at mg kg in an industry standard model for such testing in diet induced HFHC obese rats Furthermore the loss was primarily due to loss of fat while lean body mass percent remained constant in the treated animals see Phase I report No adverse effects of drug treatment were seen with repeated dosing of mg kg We therefore have a therapeutic index TI of at least using mg kg as the dose that elicited at least weight loss FDA requires at least We find these results to be promising and our Specific Aim of this proposal is to file an IND for testing safety of this compound in a clinical Phase I trial To that
end we will carry out well known IND enabling studies that we expect will results in a successful IND filing by the end of this Phase II proposal During the course of these studies we will be running our back up program in parallel using internal funds If at any point our lead compound fails a key test we will be able to replace it rapidly with a back up compound Properties of some back up compounds were discussed in the Phase I proposal Additional compounds are also available PUBLIC HEALTH RELEVANCE Obesity affects million adults in the US and over one billion adults globally For the most part obesity remains an unmet clinical condition This is a project to develop the first highly effective and safe weight loss drug that will also have positive effect on body composition

* Information listed above is at the time of submission. *

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